The Recall Desk
ModerateFDA (Drugs)·D-1672-2012·Announced 2012-09-05

Hospira Recalls Propofol Injectable Vials Due to Particulate Matter

Hospira Inc. is recalling 56,420 vials of Propofol Injectable Emulsion because a visible particulate was found during inspection.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter in an injectable drug. While Class II recalls are generally moderate, the specific finding of a single visible particulate in a sample bottle during inspection, without reported injuries or deaths, aligns with the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Hospira Inc. is recalling 56,420 vials of Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial. The recall is due to the presence of particulate matter, specifically a single visible particulate that was observed and confirmed in a sample bottle during retain inspection.

The affected product is distributed nationwide. The specific lot codes involved are 07-893-DJ (exp. 7/2013), 10-123-DJ, and 10-125-DJ (exp. 10/2013). The product is a prescription-only medication used for general anesthesia.

Healthcare providers and patients should check their inventory for these specific lot codes and expiration dates. If the product is found, it should be quarantined and not administered. Hospira Inc. is the recalling firm.

The recalled product

Product
PROPOFOL (PROPOFOL)
Brand
PROPOFOL
Manufacturer
Hospira Inc.
Affected units
56,420

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 07-893-DJ
  • exp. 7/2013
  • 10-123-DJ
  • 10-125-DJ
  • exp. 10/2013

Distribution

Distributed nationwide across the United States.